This Week in BMJ | Editor's Choice | Press releases | Advertisement details BMJ No 7092 Volume 314 Letters Saturday 17 May 1997
Alderson and Montgomery argue that children can and should play a greater part in decisions about their own health care.(2) They recommend that any child who can express a view should be given information, listened to, and have his or her views taken into account when decisions about treatment are being considered. Their suggestions for a statutory description of capacity would be present when a child understands the type and purpose of the proposed treatment, the nature and effects of the treatment in broad terms, the principal benefits and risks, and the consequences of not receiving treatment and when he or she has the capacity to choose whether to accept the treatment. When children are competent to take responsibility for a decision the responsibility for that decision would become theirs. They argue that young people from the age of 5 - that is, of compulsory school age - should be presumed competent. The young age was chosen as the presumption does not exclude parents from discussion. It also encourages recognition that young children may be competent to make certain decisions - for example, whether to take more analgesics, if not more complex ones - and allows for the children to be deemed not competent and for their decisions to be overruled, especially if their decision would result in serious irreparable harm to their health. Perhaps these criteria could be used as a basis for discussion when considering how to assess children and young people's competence to consent to participation in research. This would be in line with Doyal's additional statement that 'the levels of autonomy that patients who are thus incompetent do possess should still be respected (for example, if they resist participation then it should not be forced).' (1) A third point is that, just as in adults, competence in children is not something which is merely present or absent. Its presence may vary in children of the same age, depending on when, where, and how the question is asked, the cognitive capacities of the child at that time, and the level of competence(3) required - for example, the mere ability to assent or a full understanding of the decision and the possible consequences for the individual. Moli Paul, Parkview Clinic, References 1 Doyal L. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997;314:1107-11. (12 April.) 2 Alderson P, Montgomery J. Health care choices: making decisions with children. London: Institute for Public Policy Research, 1996. 3 Appelbaum PS, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1988;319:1635. Research in patients with mental retardation poses special problemsEditor,In response to the editorial by Richard Smith and the articles on informed consent in biomedical research by Len Doyal and Jeffrey S Tobias,(1-3) I suggest that the issues surrounding incompetent patients as in cases of mental illness or mental retardation are particularly important. People with mental retardation warrant specific mention, especially because those with severe degrees of disability will never be able to exercise their right to autonomous decision making. Yet, they as patients have the most intensive needs and have increased rates of challenging behaviour or mental illness, or both, and the treatments for these conditions remain symptomatic and have probably been investigated (originally) only in normal subjects. The advent of community care for this population and the emphasis on social care(4) has created a resistance to research carried out in children and adults with learning disabilities, further aided by the ever present and gruesome memories of the eugenics movement in the early 20th century and the Nazi experiments. However, time and again, clinicians are faced with intractable disorders in their patients with learning disabilities which compromise the patient's quality of life, may be extremely stressful to manage and cope with, and may put other residents and staff at risk. In addition, self injurious behaviour may be extremely severe, thus compounding the effects of the disability. Research on the pharmacological treatment of developmental disorders has been mainly based on small scale studies with inadequate methodology - that is, the use of antipsychotics/antidepressants and opioid antagonists in severe and unremitting aggression and self injurious behaviour. Evidence is still scant on the advantages and disadvantages of the different types of drugs for controlling challenging behaviour, with serious financial and clinical practice implications. It is a pity that the recent advances in medical technology and non-invasive procedures and improved understanding of the interaction between brain function and environment, which could yield important results for patients with learning disabilities, are not used to their full potential. Doyal's guidelines(2) certainly go some way towards addressing the issue of consent with incompetent patients, although more work, such as canvassing views of service users and carers and promoting advocacy for this client group, will be necessary before the stigma of unethical research stops beneficial treatments from being used. A Hassiotis, Department of Psychiatry and Behavioural Sciences, References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Doyal L. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997;314:1107-11. (12 April.) 3 Tobias J S. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-4. (12 April.) 4 Neuroscience Approach to Human Health Initiative Steering Committee. Mental handicap research: new technologies and approaches. Report of the workshop organised under the initiative of the Neuroscience Approach to Human Health Initiative Steering Committee. Warwick: University of Warwick, 1993. Studies with important conclusions but without patient consent should be publishedEditor,Your debate on informed patient consent for medical research this week made fascinating reading, and the situations where informed consent is, and is not, appropriate were comprehensively discussed by Len Doyal and Jeffrey S Tobias. (1,2) That a study is methodologically sound so that meaningful conclusions can be drawn is of paramount importance and is the greatest problem we face in medical research. While those authors who have spent time and effort in designing a study adequate to produce a sound paper will probably also have obtained informed consent in appropriate cases, this will not be a perfect correlation, partly because of varying interpretations of what constitutes an appropriate case. An occasional paper will therefore emerge with valid and important conclusions, but no patient consent. A prohibition on publication of papers without patient consent would cause valuable information to be absent from the literature, a scientifically and morally unacceptable situation. Each paper should be judged on its merits, with the appropriate presence of informed consent representing an important, but not paramount, consideration. The BMJ's present policy of sometimes publishing research in which patients have not given fully informed consent is indeed wholly correct. Mark F G Hulbert, Moorfields Eye Hospital, References 1 Doyal L. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997;314:1107-11. (12 April.) 2 Tobias J.BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-4. (12 April.) Failure to publish completed randomised controlled trials is unethical in itselfEditor,In response to Richard Smith's request for help in deciding the BMJ's policy on informed consent,(1) we would argue strongly in favour of maintaining the journal's present position. Nobody wishes to promote unethical research, but failure to publish completed randomised controlled trials is unethical in its own right: the efforts of all those who participated in the trial are wasted, and both health professionals and patients are deprived of information that they may need to make informed decisions.(2) There is a good deal of hypocrisy in clinical medicine about informed consent. Many so called established treatments have been poorly evaluated so that their true benefits and risks remain unclear. These treatments should still be regarded as experimental and yet, because they are accepted, they are widely given without any form of consent being required. For example, many treatments are widely used in different countries to treat patients with acute stroke-for example, aspirin, heparin, glycerol, haemodilution, corticosteroids, ancrod(3,4) - but none of these have definitely been shown to reduce the risk of death or disability and many could be harming patients - for example, antithrombotic agents could increase the risk of intracranial haemorrhage.(5) Many more patients are exposed to this abuse of consent than in randomised controlled trials but this is rarely questioned. Hardening of the already stringent requirements for informed consent in randomised controlled trials will lead to fewer and smaller randomised trials and continued uncertainty over the risks and benefits of many treatments and hence to continued widescale abuse of patients' consent in clinical practice. Carl E Counsell*, Department of Clinical Neurosciences, * Peter A G Sandercock is the principal investigator in the international stroke trial (a randomised trial of aspirin and heparin in 20,000 patients with acute stroke) and both authors are members of the Cochrane Stroke Group and of the same department as Martin Dennis et al, whose randomised controlled trial evaluating stroke family workers was published in the 12 April issue of the BMJ (pp1071-7). References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8. 3 Lindley R I, Amayo E O, Marshall J, Sandercock P A G, Dennis M, Warlow C P. Acute stroke treatment in UK hospitals: the Stroke Association survey of consultant opinion. J R Coll Physicians Lond 1995;29:479-84. 4 Ricci S, Celani M G, Righetti E, Cantisani A T for the International Stroke Trial Collaborative Group. Between country variations in the use of medical treatments for acute stroke: an update [abstract]. Cerebrovascular Diseases 1996;6(suppl 2):133. 5 Warlow C, Van Gijn J, Sandercock P, eds. Stroke module of the Cochrane database of systematic reviews [updated 4 March 1997]. Oxford: Update Software, 1997. (Updated quarterly.) Subjects may be coerced into participating in studiesEditor,Whether prospective research with no explicit statement about informed consent should be published is an issue avoided by journals for too long.(1) Subjects in some experiments believe that they are receiving standard treatment when there is no evidence of utility.(2-4) Recently I reviewed a prospective multicentre study of myocardial infarction in which the end points included death. There was no statement about ethics approval or informed consent. I suggested that if this was not an oversight the journal 'would have to decide whether it wants to publish an unethical trial.' When subjects give informed consent the experiments may still be unethical if consent is not given freely. Subjects may be coerced by poverty into participation or find it difficult to refuse a request from an employer, colleague, or teacher. I am aware of recent research involving military staff who were ordered to volunteer. I have particular concerns about research in diving medicine. Most is performed outside hospitals and without the safeguard of hospital ethics committees. In Diver magazine I reported that volume 9 of Undersea and Hyperbaric Physiology contained 111 scientific papers, of which 47 described human research.(5) Twelve studies were on patients and 35 on so called volunteers, who were often military staff or employees of the commercial diving organisations that conducted the research. Only seven papers mentioned that ethics approval was granted and only 12 mentioned informed consent. Some experiments were highly hazardous and might be best described as adventures in survival for the participants. Many studies failed to mention adverse effects. When they did, it was evident that at least 38 of the so called volunteers had decompression illness in studies which were often too small or incorrectly designed to give a statistically valid result. Senior institutions are not above reproach. Eight years ago the Medical Research Council Decompression Sickness Panel proposed introducing 'professional diver super medicals.' Like the current medical assessments, the super medicals would be performed at intervals during a diver's career but would include additional expensive investigations such as radionuclide scanning. The results were to be used in a prospective survey of long term health hazards of diving, but the divers were to be told that it was for individual screening and that they would be asked to pay for the investigations. Those who refused would lose their licence and livelihood. The plan was abandoned only recently, though I and others expressed concerns about the ethics when it was first proposed. Peter Wilmshurst, Royal Shrewsbury Hospital, References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Adkisson G H, Macleod M A, Hodgson M, Sykes J J W, Smith F, Strack C, et al. Cerebral perfusion deficits in dysbaric illness. Lancet 1989;ii:119-22. 3 Wilmshurst P T, Nunan T O. Cerebral perfusion deficits in dysbaric illness.Lancet 1989;ii:674-5. 4 Adkisson G H. Cerebral perfusion deficits in dysbaric illness. Lancet 1989;ii:675. 5 Wilmshurst P. Ethical or not? Diver 1992;37(9):85.
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